FDA.reportPublic FDA data

Varenicline

Product NDC
33342-490
11-digit product format
333420490
Labeler code
33342
Product ID
33342-490_c6a5644a-f80a-4e20-9850-aea0360a76fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varenicline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA215048
Marketing category
ANDA
Marketing start
2024-12-10
Substance
VARENICLINE TARTRATE
Active strength
1 mg/1
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Varenicline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636671, 636676, 749289

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-490-19Varenicline56 in 1 BOTTLETABLET, FILM COATED563
33342-490-27Varenicline56 in 1 BLISTER PACKTABLET, FILM COATED563
33342-490-27Varenicline1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-490VARENICLINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20250521_c325d582-8f43-40ea-b348-87837de97a07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCKc325d582-8f43-40ea-b348-87837de97a073
636671varenicline 0.5 MG Oral TabletPSNc325d582-8f43-40ea-b348-87837de97a073
636676varenicline 1 MG Oral TabletPSNc325d582-8f43-40ea-b348-87837de97a073
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNc325d582-8f43-40ea-b348-87837de97a073
636671varenicline 0.5 MG Oral TabletSCDc325d582-8f43-40ea-b348-87837de97a073
636676varenicline 1 MG Oral TabletSCDc325d582-8f43-40ea-b348-87837de97a073
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYc325d582-8f43-40ea-b348-87837de97a073
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYc325d582-8f43-40ea-b348-87837de97a073
749289varenicline first month of therapy PackSYc325d582-8f43-40ea-b348-87837de97a073
749289varenicline starting month Pack, 53 Oral TabletsSYc325d582-8f43-40ea-b348-87837de97a073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-490-193334204901956 TABLET, FILM COATED in 1 BOTTLE (33342-490-19) 2024-12-10NoNoCurrent
33342-490-27333420490271 BLISTER PACK in 1 CARTON (33342-490-27) / 56 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-12-10NoNoCurrent